Frailty in the Elderly Oncological and Oncohematological Patient.

The Italian population is progressively aging, and cancer incidence increases with age. Older patients are at higher risk of frailty, a condition associated with adverse outcomes such as disability, falls, hospitalization, and mortality.

Key indicators of frailty include reduced balance, impaired physical activity, cognitive decline, and particularly sarcopenia, defined as the progressive loss of skeletal muscle mass and strength. After age 60, muscle mass decreases by 1.4-2.5% annually, while muscle strength declines by 15% between ages 60-70 and by up to 30% per decade thereafter.

Sarcopenia increases the risk of falls, fractures, hospitalization, and non-cancer-related death. In cancer patients, its prevalence ranges from 11% to 74% and is associated with poorer survival outcomes in both early and advanced disease stages.In clinical oncology practice, several tools are available to assess frailty, identify vulnerable patients, and personalize care, treatment, and supportive interventions.

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Key information

Conditions

Sarcopenia in Elderly Atrophy Frailty Frailty/Sarcopenia Hematologic Disease Hematologic Diseases Hemic and Lymphatic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Oncological Patients Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Trial Office-ASST Ovest Milanese

Legnano, Italy, 20025

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients with solid tumors:

Cytological or histological diagnosis of lung cancer or gastrointestinal tract tumors (esophageal, gastric, intestinal, colorectal, pancreatic, and biliary tract cancers), mesothelioma.
Age ≥ 70 years
Patients deemed eligible, at the investigator's discretion, for first-line treatment including at least one chemotherapeutic agent
Previous treatments (e.g., adjuvant therapy) are allowed if completed at least one year prior to randomization
ECOG performance status 0, 1, or 2
Written informed consent obtained

Inclusion criteria

for patients with hematologic malignancies:

Cytological or histological diagnosis of multiple myeloma or lymphoma
Age ≥ 70 years
Patients deemed eligible, at the investigator's discretion, for first-line systemic treatment
ECOG performance status 0, 1, 2, or 3
Written informed consent obtained

Exclusion criteria

Brain metastases (in solid tumors)
Symptomatic bone lesions (in solid tumors)
Cardiac disease classified as NYHA class III or IV
Current or prior prostate or breast cancer receiving hormonal therapy (GnRH agonists or antagonists, androgen inhibitors, estrogen inhibitors)
Acute leukemia
Patients with pacemakers or implantable cardioverter-defibrillators (ICD)

Treatment and study plan

frailty evaluation

Other

Evaluation of the frailty impact on the toxicity grade 3-4 in patients undergoing chemotherapy treatment.

Primary outcomes

Impact of frailty on grade 3-4 Chemotherapy Toxicity in Patients with Solid and Hematologic Malignancies.

Time frame: 12 months from screening

Evaluation of the impact of frailty on the probability of grade 3 or 4 toxicity in patients with solid or hematologic malignancies undergoing chemotherapy treatment.

Multidimensional geriatric assessment including:

G8 (0-17): ≤14 = frail/vulnerable; >14 = normal. IADL (0-8): higher scores indicate greater independence. CCI: 0-2 = low comorbidity; ≥3 = high comorbidity burden. SPPB (0-12): 10-12 = good, 7-9 = intermediate, ≤6 = poor physical performance. MUST: 0 = low, 1 = medium, ≥2 = high risk of malnutrition. Mini-Cog (0-5): ≥3 = normal cognition; <3 = cognitive impairment. CARG: low, intermediate, or high risk of severe chemotherapy toxicity. MNA: ≥24 = normal; 17-23.5 = at risk of malnutrition; <17 = malnourished. Laboratory tests: routine pre-chemotherapy assessments according to institutional standards.

BIA: evaluation of body composition, muscle mass, and phase angle. CT/MRI: assessment of muscle area at L3/L4; sarcopenia defined as <4.8 cm²/m² in women and <6.6 cm²/m² in men

Secondary outcomes

Identification of Sarcopenia and Frailty through Clinical Assessment

Time frame: 12 months from the screening

Agreement between CT/MRI and BIA for sarcopenia diagnosis and association with geriatric and laboratory parameters.

G8 (0-17): ≤14 = frail/vulnerable; >14 = normal. IADL (0-8): higher scores indicate greater independence. CCI: 0-2 = low comorbidity; ≥3 = high comorbidity burden. SPPB (0-12): 10-12 = good, 7-9 = intermediate, ≤6 = poor physical performance. MUST: 0 = low, 1 = medium, ≥2 = high risk of malnutrition. Mini-Cog (0-5): ≥3 = normal cognition; <3 = cognitive impairment. CARG: low, intermediate, or high risk of severe chemotherapy toxicity. MNA: ≥24 = normal; 17-23.5 = at risk of malnutrition; <17 = malnourished. Laboratory tests: routine pre-chemotherapy assessments according to institutional standards.

BIA: evaluation of body composition, muscle mass, and phase angle. CT/MRI: assessment of muscle area at L3/L4; sarcopenia defined as <4.8 cm²/m² in women and <6.6 cm²/m² in men.
Correlation of Radiological, Functional, Clinical, and Laboratory Assessments in the Diagnosis of Sarcopenia and Frailty

Time frame: 12 months from screening

Evaluation of the concordance between sarcopenia diagnosed through radiological imaging (CT/MRI) and that obtained through a functional assessment (bioelectrical impedance analysis), the correlation between instrumental assessments and clinical parameters (comprehensive geriatric assessment) for the diagnosis of sarcopenia/frailty, and the correlation between laboratory values and clinical-instrumental measures.

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano

Other

Registry information

Official study title

Impatto Della Diagnosi di fragilità Sulla tossicità da Terapia in Pazienti Anziani Affetti da Tumore oncoLogIco e onCoEmatologico.

Acronym: SALICE

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2028
First posted: Jun 3, 2026
Registry last updated: Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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